Intervertebral implant

ABSTRACT

An adjustable spinal fusion intervertebral implant including upper and lower body portions each having proximal and distal surfaces at proximal and distal ends thereof. The implant can include a proximal wedge member disposed at the proximal ends of the respective ones of the upper and lower body portions, and a distal wedge member disposed at the distal ends of the respective ones of the upper and lower body portions. First and second linkages can connect the upper and lower body portions. Rotation of an actuator shaft can cause the distal and proximal wedge members to be drawn together such that longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces causes separation of the upper and lower body portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/347,012, filed Nov. 9, 2016, which is a continuation of U.S.application Ser. No. 13/789,507, filed Mar. 7, 2013, the disclosures ofboth of which are hereby incorporated by reference as if set forth intheir entirety herein.

BACKGROUND Field

The present invention relates to medical devices and, more particularly,to an intervertebral implant.

Description of the Related Art

The human spine is a flexible weight bearing column formed from aplurality of bones called vertebrae. There are thirty three vertebrae,which can be grouped into one of five regions (cervical, thoracic,lumbar, sacral, and coccygeal). Moving down the spine, there aregenerally seven cervical vertebra, twelve thoracic vertebra, five lumbarvertebra, five sacral vertebra, and four coccygeal vertebra. Thevertebra of the cervical, thoracic, and lumbar regions of the spine aretypically separate throughout the life of an individual. In contrast,the vertebra of the sacral and coccygeal regions in an adult are fusedto form two bones, the five sacral vertebra which form the sacrum andthe four coccygeal vertebra which form the coccyx.

In general, each vertebra contains an anterior, solid segment or bodyand a posterior segment or arch. The arch is generally formed of twopedicles and two laminae, supporting seven processes—four articular, twotransverse, and one spinous. There are exceptions to these generalcharacteristics of a vertebra. For example, the first cervical vertebra(atlas vertebra) has neither a body nor spinous process. In addition,the second cervical vertebra (axis vertebra) has an odontoid process,which is a strong, prominent process, shaped like a tooth, risingperpendicularly from the upper surface of the body of the axis vertebra.Further details regarding the construction of the spine may be found insuch common references as Gray's Anatomy, Crown Publishers, Inc., 1977,pp. 33-54, which is herein incorporated by reference.

The human vertebrae and associated connective elements are subjected toa variety of diseases and conditions which cause pain and disability.Among these diseases and conditions are spondylosis, spondylolisthesis,vertebral instability, spinal stenosis and degenerated, herniated, ordegenerated and herniated intervertebral discs. Additionally, thevertebrae and associated connective elements are subject to injuries,including fractures and torn ligaments and surgical manipulations,including laminectomies.

The pain and disability related to the diseases and conditions oftenresult from the displacement of all or part of a vertebra from theremainder of the vertebral column. Over the past two decades, a varietyof methods have been developed to restore the displaced vertebra totheir normal position and to fix them within the vertebral column.Spinal fusion is one such method. In spinal fusion, one or more of thevertebra of the spine are united together (“fused”) so that motion nolonger occurs between them. Thus, spinal fusion is the process by whichthe damaged disc is replaced and the spacing between the vertebrae isrestored, thereby eliminating the instability and removing the pressureon neurological elements that cause pain.

Spinal fusion can be accomplished by providing an intervertebral implantbetween adjacent vertebrae to recreate the natural intervertebralspacing between adjacent vertebrae. Once the implant is inserted intothe intervertebral space, osteogenic substances, such as autogenous bonegraft or bone allograft, can be strategically implanted adjacent theimplant to prompt bone in-growth in the intervertebral space. The boneingrowth promotes long-term fixation of the adjacent vertebrae. Variousposterior fixation devices (e.g., fixation rods, screws etc.) can alsobe utilize to provide additional stabilization during the fusionprocess.

Recently, intervertebral implants have been developed that allow thesurgeon to adjust the height of the intervertebral implant. Thisprovides an ability to intra-operatively tailor the intervertebralimplant height to match the natural spacing between the vertebrae. Thisreduces the number of sizes that the hospital must keep on hand to matchthe variable anatomy of the patients.

In many of these adjustable intervertebral implants, the height of theintervertebral implant is adjusted by expanding an actuation mechanismthrough rotation of a member of the actuation mechanism. In someintervertebral implants, the actuation mechanism is a screw or threadedportion that is rotated in order to cause opposing plates of the implantto move apart. In other implants, the actuation mechanism is a helicalbody that is counter-rotated to cause the body to increase in diameterand expand thereby.

Furthermore, notwithstanding the variety of efforts in the prior artdescribed above, these intervertebral implants and techniques areassociated with another disadvantage. In particular, these techniquestypically involve an open surgical procedure, which results higher cost,lengthy in-patient hospital stays and the pain associated with openprocedures.

Therefore, there remains a need in the art for an improvedintervertebral implant. Preferably, the implant is implantable through aminimally invasive procedure. Further, such devices are preferably easyto implant and deploy in such a narrow space and opening while providingadjustability and responsiveness to the clinician.

SUMMARY OF THE INVENTION

Certain aspects of this disclosure are directed toward an adjustablespinal fusion intervertebral implant. The implant can include upper andlower body portions each having proximal and distal surfaces at proximaland distal ends thereof. The proximal and distal surfaces of the upperand lower body portions can generally face each other. The implant caninclude a proximal wedge member disposed at the proximal ends of therespective ones of the upper and lower body portions, and a distal wedgemember disposed at the distal ends of the respective ones of the upperand lower body portions. The implant can include first and secondlinkages each connected to the upper and lower body portions. Theimplant can include an actuator shaft received between the upper andlower body portions. The actuator shaft can extend intermediate thedistal and proximal wedge members. Rotation of the actuator shaft cancause the distal and proximal wedge members to be drawn together suchthat longitudinal movement of the distal wedge member against the distalsurfaces and the longitudinal movement of the proximal wedge memberagainst the proximal surfaces causes separation of the upper and lowerbody portions. The implant features described in the specification canbe included in any of the implant embodiments.

In some embodiments. The proximal surfaces of the respective ones of theupper and lower body portions each define a proximal slot therein, anddistal surfaces of the respective ones of the upper and lower bodyportions each define a distal slot therein. In certain aspects, theslots of the proximal and distal surfaces of the upper and lower bodyportions are generally dove-tailed. In certain aspects, the proximalwedge member and the distal wedge member can each include upper andlower guide members extending at least partially into the respectiveones of the proximal and distal slots of the upper and lower bodyportions with at least a portion of the proximal wedge member and thedistal wedge member contacting the proximal and distal surfaces of theupper and lower body portions. The guide members of the proximal anddistal wedge members can be generally dovetailed.

In some embodiments, each of the upper and lower body portions caninclude a first side portion having an extending portion and a secondside portion having a receiving portion. The first side portion of theupper body portion can be configured to mate with the second sideportion of the lower body portion. The second side portion of the upperbody portion can be configured to mate with the first side portion ofthe lower body portion. In certain aspects, the first and second sideportions of the upper body portion can be configured to disengage fromthe first and second side portions of the lower body portion when theimplant is in an expanded state.

In some embodiments, the proximal and distal surfaces of the upper andlower body portions can be sloped.

In some embodiments, the upper and lower body portions comprisegenerally arcuate respective upper and lower exterior engagementsurfaces.

In some embodiments, the proximal wedge member can include ananti-rotational element. The anti-rotational engagement can beconfigured to engage an implant tool to prevent rotation of the implantwhen the actuator shaft is rotated relative to the implant. In certainaspects, the anti-rotational element can include a pair of aperturesextending into the proximal wedge member.

In some embodiments, each of the first and second linkages can includeat least one cam path. In certain aspects, a pin can extend from the atleast one cam path to one of the upper and lower body portions.

In some embodiments, a length of the implant varies from about 45 mm toabout 54 mm and/or a height of the implant varies from about 6.5 mm toabout 12 mm during the separation of the upper and lower body portions.In certain aspects, the length of the implant varies from about 21 mm toabout 31 mm during the separation of the upper and lower body portions.

In some embodiments, the upper and lower body portions can be coatedwith a bio-active coating, including, but not limited to, ahydroxyapatite coating, a titanium plasma spray, a resorbable blastmedia coating, or composite coatings.

Certain aspects of this disclosure are directed toward a method ofmanufacturing an adjustable spinal fusion intervertebral implant. Themethod can include extending an actuator shaft from a proximal wedgemember to a distal wedge member. The method can include engaging theproximal and distal wedge members with each of the upper and lower bodyportions. The method can include connecting first and second linkages toeach of the upper and lower body portions. The method of manufacturingsteps described in the specification can be included in any of theembodiments discussed herein.

In some embodiments, extending the actuator shaft from the proximalwedge member to the distal wedge member can include inserting theactuator shaft through a central aperture of the proximal wedge memberand through a central aperture of the distal wedge member.

In some embodiments, engaging the proximal and distal wedge members witheach of the upper and lower body portions can include extending upperand lower guide members of the proximal and distal wedge members atleast partially into respective ones of proximal and distal slots of theupper and lower body portions.

In some embodiments, the method can include engaging a first sideportion of the upper body portion and a second side portion of the lowerbody portion. The first side portion can have an extending portion, andthe second side portion can have a receiving portion. The receivingportion can be configured to receive the extending portion.

In some embodiments, engaging the first and second linkages with each ofthe upper and lower body portions can include extending a pin from a campath of one of the first and second linkages to one of the upper andlower body portions.

In some embodiments, the method can include shot-peering the upper andlower body portions.

In some embodiments, the method can include coating the upper and lowerbody portions with a bio-active coating, including, but not limited to,a hydroxyapatite coating, a titanium plasma spray, a resorbable blastmedia coating, or composite coatings.

Certain aspects of this disclosure are directed toward a method ofimplanting an expandable intervertebral implant. The method can includepositioning the implant between two vertebral bodies. The method caninclude rotating a screw mechanism of the implant to cause proximal anddistal wedge members to converge toward each other and engage respectiveones of proximal and distal surfaces of upper and lower body portions ofthe implant. The method can include separating the upper and lower bodyportions to cause the implant to expand. In certain aspects, separatingthe upper and lower body portions can cause first and second linkages torotate from a first configuration to a second configuration. The methodof use steps discussed in the specification can be included in any ofthe embodiments described herein.

In some embodiments, a height of the first and second linkages can begreater in the second configuration than in the first configuration.

In some embodiments, the method can include moving one or more pinsalong a respective cam path of one of the first and second linkages tocause the first and second linkages to rotate from the firstconfiguration to the second configuration.

For purposes of summarizing the disclosure, certain aspects, advantagesand features of the inventions have been described herein. It is to beunderstood that not necessarily any or all such advantages are achievedin accordance with any particular embodiment of the inventions disclosedherein. No aspects of this disclosure are essential or indispensable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an intervertebral implant in an unexpandedstate while positioned intermediate adjacent vertebrae, according to anembodiment.

FIG. 2 is a side view of the intervertebral implant shown in FIG. 1 inan expanded state.

FIG. 3 is a perspective view of the intervertebral implant shown in FIG.1 in an unexpanded state.

FIG. 4 is a perspective view of the intervertebral implant shown in FIG.1 in an expanded state.

FIG. 5 is a side cross sectional view of the intervertebral implantshown in FIG. 3 in an unexpanded state, the cross sectional view istaken along line 5-5 of FIG. 3.

FIG. 6 is a side cross sectional view of the intervertebral implantshown in FIG. 3 in an unexpanded state, the cross sectional view istaken along line 6-6 of FIG. 3.

FIG. 7 is a side cross-sectional view of the intervertebral implantshown in FIG. 4 in an expanded state, the cross-sectional view is takenalong line 7-7 of FIG. 4.

FIG. 8 is a side cross-sectional view of the intervertebral implantshown in FIG. 4 in an expanded state, the cross-sectional view is takenalong line 8-8 of FIG. 4.

FIG. 9 is a bottom view of the intervertebral implant shown in FIG. 1 inan unexpanded state.

FIG. 10 is a side view of the intervertebral implant shown in FIG. 1 inan expanded state.

FIG. 11 is a front cross-sectional view of the intervertebral implantshown in FIG. 10 taken along lines 11-11.

FIG. 12 is a top perspective view of an upper body portion of theintervertebral implant shown in FIG. 1.

FIG. 13 is a bottom perspective view of the upper body portion of theintervertebral implant shown in FIG. 1.

FIG. 14 is a perspective view of an actuator shaft of the intervertebralimplant shown in FIG. 1.

FIG. 15 is a front perspective view of a proximal wedge member of theintervertebral implant shown in FIG. 1.

FIG. 16 is a rear perspective view of the proximal wedge member of theintervertebral implant shown in FIG. 1.

FIG. 17 is a front perspective view of a distal wedge member of theintervertebral implant shown in FIG. 1.

FIG. 18 is a rear perspective view of the distal wedge member of theintervertebral implant shown in FIG. 1.

FIG. 19A illustrates a perspective view of a linkage of theintervertebral implant shown in FIG. 1.

FIG. 19B illustrates a side view of the linkage illustrated in FIG. 19A.

FIG. 19C illustrates a top view of the linkage illustrated in FIG. 19A.

FIG. 20 is a perspective view of a long pin of the intervertebralimplant shown in FIG. 1.

FIG. 21 is a perspective view of a short pin of the intervertebralimplant shown in FIG. 1.

DETAILED DESCRIPTION

In accordance with certain embodiments disclosed herein, an improvedintervertebral implant is provided that allows the clinician to insertthe intervertebral implant through a minimally invasive procedure. Forexample, one or more intervertebral implants can be insertedpercutaneously to reduce trauma to the patient and thereby enhancerecovery and improve overall results of the surgery.

An intervertebral implant can include a plurality of body sections thatare selectively separable and expandable upon contraction of a centrallydisposed actuator. The actuator can be utilized to contract againstfaces of the body sections to cause the expansion thereof. The implantcan also be configured such that the actuator provides for both theexpansion and contraction of the body sections. The actuator cancomprise an interaction between the body sections and another element,an action performed by another element, or a combination of interactionsbetween various elements of the implant and its body sections. Further,the implant can be configured to allow either rough or fine incrementaladjustments in the expansion of the implant.

The embodiments disclosed herein are discussed in the context of anintervertebral implant and spinal fusion because of the applicabilityand usefulness in such a field. As such, various embodiments can be usedto properly space adjacent vertebrae in situations where a disc hasruptured or otherwise been damaged. As also disclosed herein,embodiments can also be used as vertebral body replacements. Thus,“adjacent” vertebrae can include those originally separated only by adisc or those that are separated by intermediate vertebra and discs.Such embodiments can therefore tend to recreate proper disc height andspinal curvature as required in order to restore normal anatomicallocations and distances. However, it is contemplated that the teachingsand embodiments disclosed herein can be beneficially implemented in avariety of other operational settings, for spinal surgery and otherwise.

For example, the implant disclosed herein can also be used as avertebral body replacement. In such a use, the implant could be used asa replacement for a lumbar vertebra, such as one of the L1-L5 vertebrae.Thus, the implant could be appropriately sized and configured to be usedintermediate adjacent vertebrae, or to entirely replace a damagedvertebra.

It is contemplated that the implant can be used as an interbody orintervertebral device or can be used to replace a vertebral bodyentirely. The implant can also be used in vertebral body compressionfractures. Further, the implant can be used as a tool to expand anintervertebral space or bone in order to fill the space or bone with acement; in such cases, the implant can be removed or left in once thecement is placed. Furthermore, the implant can also be used as a tool topre-dilate the disc space. In some embodiments, the implant can beremoved once the disc space is dilated, and a different implant(expandable or non-expandable) can then be implanted in the dilated discspace. The implant can also be introduced into the disc space anteriorlyin an anterior lumbar interbody fusion (ALIF) procedure, posterior in anposterior lumbar interbody fusion (PILF) or posterior lateral interbodyfusion, from extreme lateral position in an extreme lateral interbodyfusion procedure (XLIF) or direct lateral interbody fusion (DLIF), froma far lateral position in a transforaminal lumbar interbody fusion(TLIF), to name a few. In other arrangements, the implant can beinserted through the Kambin triangle or be inserted through the Kambintriangle after the Kambin triangle has been enlarged via removing bone(e.g., techniques such as PerX360® System™ sold by Intervention Spine®).Although the implant is primarily described herein as being used toexpand in a vertical direction, it can also be implanted to expand in ahorizontal direction in order to increase stability and/or increasesurface area between adjacent vertebral bodies.

Therefore, it is contemplated that a number of advantages can berealized utilizing various embodiments disclosed herein. For example, aswill be apparent from the disclosure, no external distraction of thespine is necessary. Further, no distraction device is required in orderto install various embodiments disclosed herein. In this regard,embodiments of the implant can enable sufficient distraction of adjacentvertebra in order to properly restore disc height or to use the implantas a vertebral body replacement. Thus, normal anatomical locations,positions, and distances can be restored and preserved utilizing many ofthe embodiments disclosed herein.

Referring to FIG. 1, there is illustrated a side view of an embodimentof a intervertebral implant 200 in an unexpanded state while positionedgenerally between adjacent vertebrae of the lumbar portion of the spine212. FIG. 2 illustrates the intervertebral implant 200 in an expandedstate, thereby supporting the vertebrae in a desired orientation andspacing in preparation for spinal fusion. As is known in the art, spinalfusion is the process by which the adjacent vertebrae of the spine areunited together (“fused”) so that motion no longer occurs between thevertebrae. Thus, the intervertebral implant 200 can be used to providethe proper spacing two vertebrae to each other pending the healing of afusion. See also U.S. Pat. No. 7,824,429, filed Jul. 18, 2003, theentirety of the disclosure of which is hereby incorporated by reference.

In certain embodiment, the implant can be installed in an operation thatgenerally entails the following procedures. The damaged disc or vertebracan be decompressed, such as by distracting. The subject portion (orentire) disc or vertebra can then be removed. The adjacent vertebrae canbe prepared by scraping the exposed adjacent portion or plates thereof(typically to facilitate bleeding and circulation in the area).Typically, most of the nucleus of the disc is removed and the annulus ofthe disc is thinned out. Although individual circumstances may vary, itmay be unusual to remove all of the annulus or to perform a completediskectomy. The implant can then be installed. In some embodiments,distraction of the disc may not be a separate step from placement of theimplant; thus, distraction can be accomplished and can occur duringplacement of the implant. Finally, after implantation of the implant,osteogenic substances, such as autogenous bone graft, bone allograft,autograft foam, or bone morphogenic protein (BMP) can be strategicallyimplanted adjacent the implant to prompt bone in-growth in theintervertebral space. In this regard, as the implant is expanded, thespaces within the implant can be backfilled; otherwise, the implant canbe pre-packed with biologics.

The intervertebral implant is often used in combination with posteriorand/or anterior fixation devices (e.g., rods, plates, screws, etc. thatspan two or more vertebrae) to limit movement during the fusion process.U.S. Pat. No. 7,824,429 discloses a particularly advantageous posteriorfixation device and method which secures two adjacent vertebra to eachother in a trans-laminar, trans-facet or facet-pedicle (e.g., theBoucher technique) application using fixation screws.

It should also be appreciated that in FIGS. 1 and 2 only oneintervertebral implant 200 is shown positioned between the vertebrae212. However, two, three, or more implants 200 can be inserted into thespace between the vertebrae 212. Further, other devices, such as bonescrews, can be used on the vertebrae as desired. For example, in aspinal fusion procedure, it is contemplated that one or more implants200 can be used in conjunction with one or more bone screws and/ordynamic stabilization devices, such as those disclosed in theabove-mentioned U.S. Pat. No. 7,824,429, filed Jul. 18, 2003.

In certain embodiments, the implant 200 can be used in combination witha dynamic stabilization devices such as those disclosed in U.S. Pat. No.7,648,523, filed Feb. 11, 2005; U.S. Pat. No. 6,951,561, filed on May 6,2004; U.S. Pat. No. 7,998,176, filed on Jun. 6, 2008; and U.S. Pat. No.7,824,429, filed Jul. 18, 2003; the entireties of the disclosures ofwhich are hereby incorporated by reference. In this manner, the implant200 can be used to maintain height between vertebral bodies while thedynamic stabilization device provides limits in one or more degrees ofmovement.

FIG. 3 is a perspective view of an intervertebral implant 200 in anunexpanded state, and FIGS. 5 and 6 illustrate cross-sections of theintervertebral implant 200 in the unexpanded state. The implant 200 cancomprise upper and lower body portions 202, 204, proximal and distalwedge members 206, 208, first and second linkages 254, 265, and anactuator shaft 210. In the unexpanded state, the upper and lower bodyportions 202, 204 can be generally abutting with a height of the implant200 being minimized. However, the implant 200 can be expanded, as shownin FIG. 4, to increase the height of the implant 200 when implanted intothe intervertebral space of the spine. FIGS. 7 and 8 illustratecross-sections of the intervertebral implant 200 in the expanded state.

It is contemplated that the actuator shaft 210 can be rotated to causethe proximal and distal wedge members to move toward each other, thuscausing the upper and lower body portions 202, 204 to be separated. Insome embodiments, the implant 200 can include one or more linkagesconfigured to connect the upper and lower body portions 202, 204 whenthe implant 200 is in an expanded state. For example, as shown in FIGS.3 and 4, the implant 200 can include first and second linkages 254, 265.The linkages 254, 265 can be configured to move between a firstconfiguration (shown in FIG. 5) and a second configuration (shown inFIG. 7).

Each of the intervertebral implant components will be described infurther detail below in reference to FIGS. 9-21.

In some embodiments, the height of the implant 200 can be or vary withina range from at least about 6 mm to less than or equal to about 15 mm,and more preferably, from about 6.5 mm to about 12 mm. The width of theimplant can be at least about 7 mm and/or less than or equal to about 18mm, and preferably approximately 9 mm or 18 mm. Thus, the implant 200can have a preferred aspect ratio of between approximately 6:18 and15:7, and preferably approximately between 6.5:9 and 12:9, or between6.5:18 and 12:18.

The length of the implant 200 can be or vary within a range from atleast 18 mm to less than or equal to about 54 mm. In certain aspects,the length of the implant 200 can be or vary within a range from leastabout 18 mm to less than or equal to about 35 mm, and preferably fromabout 25 mm to about 31 mm. In certain aspects, the length of theimplant 200 can be or vary within a range from least about 45 mm to lessthan or equal to about 54 mm. In some embodiments, the implant can havea greater length in the unexpanded state than in the expanded state. Itis contemplated that various modifications to the dimension disclosedherein can be made by one of skill and the mentioned dimensions shallnot be construed as limiting.

The intervertebral implant components can be manufactured in accordancewith any of a variety of techniques which are well known in the art,using any of a variety of medical-grade construction materials. Forexample, the upper and lower body portions 202, 204, the actuator shaft210, and other components can be injection-molded from a variety ofmedical-grade polymers including high or other density polyethylene,PEEK™ polymers, nylon and polypropylene.

The intervertebral implant 200 components can be molded, formed ormachined from biocompatible metals such as Nitinol, stainless steel,titanium, and others known in the art. Non-metal materials such asplastics, PEEK™ polymers, and rubbers can also be used. Further, theimplant components can be made of combinations of PEEK™ polymers andmetals. In some embodiments, the intervertebral implant components canbe injection-molded from a bioabsorbable material, to eliminate the needfor a post-healing removal step.

The intervertebral implant components may be coated with or contain oneor more bioactive substances, such as antibiotics, chemotherapeuticsubstances, angiogenic growth factors, substances for accelerating thehealing of the wound, growth hormones, anti-thrombogenic agents, bonegrowth accelerators or agents, and the like. Such bioactive implants maybe desirable because they contribute to the healing of the injury inaddition to providing mechanical support. For example, in someembodiments, the upper and lower body portions 202, 204 can be coatedwith a bio-active coating, including, but not limited, to ahydroxyapatite coating, a titanium plasma spray, a resorbable blastmedia coating, or composite coatings. The upper and lower body portions202, 204 can be coated after the implant is fully assembled, such thatother components exposed along the upper and lower surfaces of theimplant can also be coated with hydroxyapatite.

In some embodiments, the intervertebral implant components can besurface treated to increase the strength of the components. For example,the intervertebral implant components can be sand blasted, shot peened,laser peened, or otherwise treated to increase strength.

In addition, the intervertebral implant components may be provided withany of a variety of structural modifications to accomplish variousobjectives, such as osteoincorporation, or more rapid or uniformabsorption into the body. For example, osteoincorporation may beenhanced by providing a micropitted or otherwise textured surface on theintervertebral implant components. Alternatively, capillary pathways maybe provided throughout the intervertebral implant, such as bymanufacturing the intervertebral implant components from an open cellfoam material, which produces tortuous pathways through the device. Thisconstruction increases the surface area of the device which is exposedto body fluids, thereby generally increasing the absorption rate.Capillary pathways may alternatively be provided by laser drilling orother technique, which will be understood by those of skill in the artin view of the disclosure herein. Additionally, apertures can beprovided in the implant to facilitate packing of biologics into theimplant, backfilling, and/or osseointegration of the implant. Ingeneral, the extent to which the intervertebral implant can be permeatedby capillary pathways or open cell foam passageways may be determined bybalancing the desired structural integrity of the device with thedesired reabsorption time, taking into account the particular strengthand absorption characteristics of the desired polymer.

The implant 200 can be at least partially radiolucent, whichradiolucency can allow a doctor to perceive the degree of bone growtharound and through the implant. The individual components of the implant200 can be fabricated of such materials based on needed structural,biological and optical properties.

The intervertebral implant may be sterilized by any of the welt-knownsterilization techniques, depending on the type of material. Suitablesterilization techniques include heat sterilization, ultrasonicsterilization, radiation sterilization, such as cobalt irradiation orelectron beams, ethylene oxide sterilization, and the like.

FIG. 9 is a bottom view of the implant 200 shown in FIG. 3. As showntherein, each of the upper and lower body portions 202, 204 can alsoinclude one or more openings 274, 276 for receiving the first and secondlinkages 254, 265 and/or receiving graft material or other bioactivesubstances. The openings 274, 276 can be disposed on either side of acentral receptacle 298 (FIG. 13).

In some embodiments, the two openings 274, 276 can be similarly shaped.For example, as shown in FIG. 9, each opening 274, 276 can include afirst elongate portion having a width and a second portion having awidth greater than the first elongate portion width. As shown in FIG. 9,at least a part of the actuator shaft 210 is visible through the secondportion of each opening 274, 276. The second opening 276 can be disposedat a 180 degree angle from the first opening 274 and/or horizontallydisplaced from the first opening 274.

In certain variants, the openings 274, 276 can be single elongateportions through which the first and second linkages 254, 265 extend.Although not shown in the FIGS., the upper and lower body portions 202,204 can include additional openings for receiving graft material orother bioactive substances. Each of the openings can be shaped similarlyor differently. The additional openings can be vertically and/orhorizontally displaced from each other along the upper and body portions202, 204. The additional opens can be aligned with a longitudinal axisof the implant 200 or positioned off-center. One or more of the openingscan be generally rounded, including, but not limited to, a generallyelliptical shape, or include a light-bulb shape. The width of one ormore of the openings can vary across a length of the opening.

In some embodiments, the implant 200 can comprise one or moreprotrusions 260 on a bottom surface 262 of the lower body portion 204.As shown in FIG. 12, the upper body portion 204 can also define a topsurface having one or more protrusions 260 thereon. The protrusions 260can allow the implant 200 to engage the adjacent vertebrae when theimplant 200 is expanded to ensure that the implant 200 maintains adesired position in the intervertebral space.

The protrusions 260 can be configured in various patterns. As shown, theprotrusions 260 can be formed from grooves extending widthwise along thebottom surface 262 of the implant 200 (also shown extending from a topsurface 264 of the upper body portion 202 of the implant 200). Theprotrusions 260 can become increasingly narrow and pointed toward theirapex. However, it is contemplated that the protrusions 260 can be one ormore raised points, cross-wise ridges, or the like.

In FIG. 9, the implant 200 is illustrated in the unexpanded state witheach of the respective slots 222 of the lower body portion 204 and lowerguide members 270, 272 of the respective ones of the proximal and distalwedge members 206, 208. In some embodiments, as shown in FIGS. 12-13,the slots and guide members can be configured to incorporate a generallydovetail shape. Thus, once a given guide member is slid into engagementwith a slot, the guide member can only slide longitudinally within theslot and not vertically from the slot. This arrangement can ensure thatthe proximal and distal wedge members 206, 208 are securely engaged withthe upper and lower body portions 202, 204.

In FIG. 10, a side view of the embodiment of the implant 200 in theexpanded state illustrates the angular relationship of the proximal anddistal wedge members 206, 208 and the upper and lower body portions 202,204. As mentioned above, the dovetail shape of the slots and guidemembers ensures that for each given slot and guide member, a given wedgemember is generally interlocked with the give slot to only provide onedegree of freedom of movement of the guide member, and thus the wedgemember, in the longitudinal direction of the given slot.

Accordingly, in such an embodiment, the wedge members 206, 208 may notbe separable from the implant when the implant 200 is in the unexpandedstate (as shown in FIG. 3) due to the geometric constraints of theangular orientation of the slots and guide members with the actuatorshaft inhibiting longitudinal relative movement of the wedge members206, 208 relative to the upper and lower body portions 202, 204. Such aconfiguration ensures that the implant 200 is stable and structurallysound when in the unexpanded state or during expansion thereof, thusfacilitating insertion and deployment of the implant 200.

Such an embodiment of the implant 200 can therefore be assembled byplacing or engaging the wedge members 206, 208 with the actuator shaft210, moving the wedge members 206, 208 axially together, and insertingthe upper guide members 230, 232 into the slots 220 of the upper bodyportion 202 and the lower guide members 270, 272 into the slots 222 ofthe lower body portion 204. The wedge members 206, 208 can then be movedapart, which movement can cause the guide members and slots to engageand bring the upper and lower body portions toward each other. Theimplant 200 can then be prepared for insertion and deployment byreducing the implant 200 to the unexpanded state.

Referring again to FIG. 10, the implant 200 can define generally convextop and bottom surfaces 264, 262. This shape can be configured togenerally match the concavity of adjacent vertebral bodies.

FIGS. 12-13 illustrate perspective views of the upper body portion 202of the implant 200, according to an embodiment. These FIGS. provideadditional clarity as to the configuration of the slots 220 andillustrate a first and second side portions 240, 242 of the upper bodyportion 202. The upper and lower body portions 202, 204 can also definea central receptacle 298 wherein the actuator shaft can be received, andtwo openings 274, 276 for receiving the first and second linkages 254,265. Although the FIGS. illustrate the actuator shaft 210 disposed alonga central receptacle 298 of the upper and lower body portions 202, 204,in certain variants, the actuator shaft 210 can be disposed off-center.This may be useful to provide a continuous graft channel along a centralportion of the implant, from the top surface of the implant to thebottom surface of the implant.

It is contemplated that some embodiments of the implant 200 can beconfigured such that the upper and lower body portions 202, 204 eachinclude side portions (shown as first side portion 240 and second sideportion 242 of the upper body portion 202) to facilitate the alignment,interconnection, and stability of the components of the implant 200. Thefirst and second side portions 240, 242 can be configured to havecomplementary structures that enable the upper and lower body portions202, 204 to move in a vertical direction an maintain alignment in ahorizontal direction. For example, as shown in FIGS. 12-13, the firstside portion 240 can include an extending portion and the second sideportion 242 can include a receiving portion for receiving the extendingportion of the first side portion 240. As shown in FIG. 10, the firstand second side portions 240, 242 of the upper body portion 202 can beconfigured to disengage from the first and second side portions 240, 242of the lower body portion 202 when the implant 200 is in the expandedstate.

FIG. 9 illustrates a bottom view of the profile of an embodiment of thefirst side portion 240 and the second side portion 242. As shown in FIG.9, having a pair of each of first and second side portions 240, 242 canensure that the upper and lower body portions 202, 204 do not translaterelative to each other, thus further ensuring the stability of theimplant 200.

In some embodiments, the implant 200 can be configured to include one ormore apertures 252 to facilitate osseointegration of the implant 200within the intervertebral space. As mentioned above, the implant 200 maycontain one or more bioactive substances, such as antibiotics,chemotherapeutic substances, angiogenic growth factors, substances foraccelerating the healing of the wound, growth hormones,anti-thrombogenic agents, bone growth accelerators or agents, and thelike. Indeed, various biologics can be used with the implant 200 and canbe inserted into the disc space or inserted along with the implant 200.The apertures 252 can facilitate circulation and bone growth throughoutthe intervertebral space and through the implant 200. In suchimplementations, the apertures 252 can thereby allow bone growth throughthe implant 200 and integration of the implant 200 with the surroundingmaterials.

As shown in FIG. 14, the actuator shaft 210 can have at least one thread294 disposed along at least a portion thereof, if not along the entirelength thereof. The actuator shaft 210 can be threadably and/or freelyattached to one or both of the proximal and distal wedge members 206,208. The actuator shaft 210 can also be configured such that a proximalportion of the actuator shaft 210 can be removed after the implant 200has been expanded in order to eliminate any proximal protrusion of theactuator shaft 210. Although, the present embodiment is illustratedusing this mode of expansion, it is contemplated that other modes ofexpansion (e.g., one way-ratchet type mechanism) can be combined with orinterchanged herewith.

The threads can be configured to be left hand threads at a distal end ofthe actuator shaft 210 and right hand threads at a proximal other end ofthe actuator shaft 210 for engaging the respective ones of the distaland proximal wedge members 208, 206. Accordingly, upon rotation of theactuator shaft 210, the wedge members 206, 208 can be caused to movetoward or away from each other to facilitate expansion or contraction ofthe implant 200.

In some embodiments, the actuator shaft 210 can facilitate expansion ofthe implant 200 through rotation, longitudinal contract of the pin, orother mechanisms. The actuator shaft 210 can include threads thatthreadably engage at least one of the proximal and distal wedge members206, 208. The actuator shaft 210 can also facilitate expansion throughlongitudinal contraction of the actuator shaft as proximal and distalcollars disposed on inner and outer sleeves move closer to each other toin turn move the proximal and distal wedge members closer together. Itis contemplated that in certain variants, at least a portion of theactuator shaft can be axially fixed relative to one of the proximal anddistal wedge members 206, 208 with the actuator shaft being operative tomove the other one of the proximal and distal wedge members 206, 208 viarotational movement or longitudinal contraction of the pin.

In some embodiments, wherein the actuator shaft 210 is threaded, it iscontemplated that the actuator shaft 210 can be configured to bring theproximal and distal wedge members closer together at different rates. Insuch embodiments, the implant 200 could be expanded to a V-configurationor wedged shape. For example, the actuator shaft 210 can comprise avariable pitch thread that causes longitudinal advancement of the distaland proximal wedge members at different rates. The advancement of one ofthe wedge members at a faster rate than the other could cause one end ofthe implant to expand more rapidly and therefore have a different heightthat the other end. Such a configuration can be advantageous dependingon the intervertebral geometry and circumstantial needs.

The actuator shaft 210 can be utilized to provide a stabilizing axialforce to the proximal and distal wedge members 206, 208 in order tomaintain the expansion of the implant 200. However, it is alsocontemplated that other features can be incorporated into such anembodiment to facilitate the maintenance of the expansion. In thisregard, although the axial force provided by the actuator shaft 210 cantend to maintain the position and stability of the proximal and distalwedge members 206, 208, additional features can be employed to ensurethe strength and stability of the implant 200 when in its expandedstate. For example, the proximal and distal wedge members 206, 208 caninclude ribbed engagement surfaces (not shown). The use of the ribbedengagement surfaces can permit one-way, ratchet type longitudinalmovement of proximal and distal wedge members 206, 208 relative to theupper and lower body portions 202, 204 in order to maintain the upperand lower body portions at a given separation distance. Various otherfeatures that can be used to facilitate the expansion of two bodyportions of an intervertebral implant are disclosed in U.S. Pat. No.8,105,382, filed Dec. 7, 2007, the entirety of which is herebyincorporated by reference.

The actuator shaft 210 can be cannulated and/or include one or moreapertures. The one or more apertures and/or cannula can provide accessto an internal portion of the implant, so bone graft or other bioactivematerials described herein can be directly injected into the implant topromote fusion.

In accordance with an embodiment, the actuator shaft 210 can alsocomprise a tool engagement section 296. The tool engagement section 296can be configured as a to be engaged by a tool 400. The tool engagementsection 296 can be shaped as a polygon, such as a hex shape tofacilitate the transfer of torque to the actuator shaft 210 from thetool 400. For example, the tool 400 can include a distal engagementmember 430 being configured to engage a proximal end of the actuatorshaft 210 of the implant 200 for rotating the actuator shaft 210 tothereby expand the implant from an unexpanded state to and expandedstate.

The proximal end of the actuator shaft can also include a number of toolengagement features configured to engage with a number of correspondingengagement features at a distal end of the tool 400 (shown in FIG. 4).These tool engagement features can be configured to increase torquestrength and facilitate rotation of the actuator shaft. As shown in FIG.14, the tool engagement features can take the form of one or moregrooves or indentations. The number of tool engagement features canequal the number of faces on the tool engagement section. For example,the actuator shaft 210 can include six tool engagement features. Thetool engagement features can be disposed at a proximal end of theactuator shaft 210, between the threaded portion 294 and the toolengagement section 296. In certain aspects, the tool engagement featurescan surround a base of the tool engagement section 296. FIG. 4illustrates the corresponding engagement features of the tool 400. Thecorresponding features can take the form of protrusions, nubs, fingers,or otherwise, at the distal end of the tool 400.

FIG. 1546 illustrate perspective views of the proximal wedge member 206of the implant 200. The proximal wedge member 206 can include one ormore anti-torque structures 250. Further, the guide members 230, 270 arealso illustrated. The proximal wedge member 206 can comprise a centralaperture 300 wherethrough an actuator shaft can be received. Whenactuator shaft 210 is used in an embodiment, the central aperture 300can be threaded to correspond to the threads 294 of the actuator shaft210. In other embodiments, the actuator shaft can engage other portionsof the wedge member 206 for causing expansion or contraction thereof.

In some embodiments, the implant 200 can be configured such that theproximal and distal wedge members 206, 208 are interlinked with theupper and lower body portions 202, 204 to improve the stability andalignment of the implant 200. For example, the upper and lower bodyportions 202, 204 can be configured to include slots (slot 220 is shownin FIG. 3, and slots 220, 222 are shown in FIG. 4). The proximal anddistal wedge members 206, 208 can be configured to include at least oneguide member (an upper guide member 230 of the proximal wedge member 206is shown in FIGS. 15-16 and an upper guide member 232 of the distalwedge member 208 is shown in FIGS. 17-18) that at least partiallyextends into a respective slot 220, 222 of the upper and lower bodyportions 202, 204. The arrangement of the slots and the guide memberscan enhance the structural stability and alignment of the implant 200.

In some embodiments, the implant 200 can be configured to includeanti-torque structures 250. The anti-torque structures 250 can interactwith at least a portion of a deployment tool during deployment of theimplant to ensure that the implant maintains its desired orientation.For example, when the implant 200 is being deployed and a rotationalforce is exerted on the actuator shaft 210, the anti-torque structures250 can be engaged by a non-rotating structure of the deployment tool tomaintain the rotational orientation of the implant 200 while theactuator shaft 210 is rotated. The anti-torque structures 250 cancomprise one or more inwardly extending holes or indentations on theproximal wedge member 206, which are shown as a pair of holes in FIGS.3-4. However, the anti-torque structures 250 can also comprise one ormore outwardly extending structures.

The tool 400 can also include an anti-torque component to engage one ormore anti-torque structures 250 of the implant 200. The anti-torquecomponent can include one or more protrusions that engage theanti-torque structures 250 to prevent movement of the implant 200 when arotational force is applied to the actuator shaft 210 via the tool 400.Other deployment methods can also be used, such as those disclosed inU.S. Pat. No. 8,105,382.

FIG. 17-18 illustrate perspective views of the distal wedge member 208of the implant 200. As similarly discussed above with respect to theproximal wedge member 206, the guide members 232, 272 and a centralaperture 302 of the proximal wedge member 206 are illustrated. Thecentral aperture 302 can be configured to receive an actuator shafttherethrough. When actuator shaft 210 is used in an embodiment, thecentral aperture 302 can be threaded to correspond to the threads 294 ofthe actuator shaft 210. In other embodiments, the actuator shaft canengage other portions of the wedge member 208 for causing expansion orcontraction thereof.

As shown in FIGS. 19A-19C, each linkage 254, 265 can have a width W anda length L. The length L can be substantially longer than the width W.In some embodiments, the length L can be at least two times the width W,at least three times the W, or otherwise. Each linkage 254, 265 caninclude one or more cam paths 282, 284 through which a long pin 258(FIG. 20) or a short pin 263 (FIG. 21) can move. Each linkage can alsoinclude shaft portions 278, 286. The axis extending through the shaftportions 278, 286 can be substantially transverse to the longitudinalaxis of the linkages 254, 265. Shaft portion 278 can be longer thanshaft portion 286.

The linkages can be positioned such that the longer shaft portion 278can engage the side portions 240, 242 of the upper and lower bodyportions 202, 204. For example, each of the side portions 240, 242 caninclude a receiving portion 293, 295 for receiving the longer shaftportion 278 when the implant 202 is in the unexpanded state. Each of theupper and lower body portions 202, 204 can also include internalreceiving portions 297, 299 for receiving the shorter shaft portions 286when the implant 200 is in the unexpanded state. The receiving portionscan be slots, grooves, indentations, or other features capable ofreceiving the shaft portions 278, 286.

The linkages 254, 265 can facilitate the alignment, interconnection, andstability of the upper and lower body portions 202, 204. As shown inFIG. 4, the long and short pins 258, 263 can connect the linkages 254,265 to the upper and lower body portions 202, 204, The upper and lowerbody portions 202, 204 can each include apertures 290, 292 for receivingthe pins 258, 263 (shown in FIGS. 12-13). For example, the long pin 258can extend from the cam path 284 to the side portion aperture 290disposed on the first side portion 240, and the short pin 263 can extendfrom the cam path 282 to the to the side portion aperture 292 disposedon the second side portion 242. FIG. 11 illustrates how the upper andlower body portions 202, 204 can connect to linkages 254, 265 via thepins 263. FIG. 11 illustrates a cross-section of FIG. 10 taken alongline 11-11.

In addition, the linkages 254, 265 can act as motion limiting structuresthat limit the separation between the upper and lower body portions 202,204. As the upper and lower side portions 202, 204 move apart, the pins258, 263 move along their respective cam paths 282, 284 and force thelinkages 254, 265 to rotate from the first configuration to the secondconfiguration. In the first configuration, an axis extending across thewidth W of each linkage 254, 265 is substantially transverse to alongitudinal axis of the implant 200. In the second configuration, theaxis extending across the width W of each linkage 254, 265 is nearly orsubstantially parallel to the longitudinal axis of the implant 200. Theupper and lower body portions 202, 204 can only move apart so far as thelinkages 254, 265 will permit. As such, the distance between the upperand lower body portions 202, 204 is limited by the distance between farends of cam paths 282, 284.

Although not shown in the FIGS., the implant 200 can include additionallinkages to provide further stability. Each of the additional linkagescan connect to the upper and lower body portions 202, 204 as describedabove. For example, the additional linkages can be horizontallydisplaced from the first and second linkages 254, 265 described herein.In certain variants, the additional linkages can connect to the firstand second linkages 254, 265 to permit further expansion of the upperand lower body portions 202, 204. For example, the upper and lower bodyportions 202, 204 can be separated by a distance equivalent to twolinkages.

The specific dimensions of any of the embodiment disclosed herein can bereadily varied depending upon the intended application, as will beapparent to those of skill in the art in view of the disclosure herein.Moreover, although the present inventions have been described in termsof certain preferred embodiments, other embodiments of the inventionsincluding variations in the number of parts, dimensions, configurationand materials will be apparent to those of skill in the art in view ofthe disclosure herein. In addition, all features discussed in connectionwith any one embodiment herein can be readily adapted for use in otherembodiments herein to form various combinations and sub-combinations.The use of different terms or reference numerals for similar features indifferent embodiments does not imply differences other than those whichmay be expressly set forth. Accordingly, the present inventions areintended to be described solely by reference to the appended claims, andnot limited to the preferred embodiments disclosed herein.

What is claimed is:
 1. An adjustable spinal fusion intervertebralimplant comprising: upper and lower body portions each having proximaland distal surfaces at proximal and distal ends thereof, the proximaland distal surfaces of the upper and lower body portions generallyfacing each other; a proximal wedge member disposed at the proximal endsof the respective ones of the upper and lower body portions; a distalwedge member disposed at the distal ends of the respective ones of theupper and lower body portions; first and second linkages each connectedto the upper and lower body portions; and an actuator shaft receivedbetween the upper and lower body portions, the actuator shaft extendingintermediate the distal and proximal wedge members, wherein rotation ofthe actuator shaft causes the distal and proximal wedge members to bedrawn together such that longitudinal movement of the distal wedgemember against the distal surfaces and the longitudinal movement of theproximal wedge member against the proximal surfaces causes separation ofthe upper and lower body portions.